Pharmac considering new price offer for melanoma drug Keytruda
Ged Stephens' family fund-raised $50,000 in the hope cancer drug Keytruda would do what chemotherapy couldn't for his advanced melanoma, but the 56-year-old never got the chance to try it.
Now there is renewed hope that other terminal melanoma patients may get the opportunity to try the drug, praised internationally as a "game changer". The government's medication purchasing body Pharmac is considering a new price offer from the drug's manufacturer.
Stephens, a Mapua volunteer firefighter, died four days before Christmas. His son Brian Stephens said Keytruda was "possibly his only chance".
The drug made headlines after its early clinical trials showed tumour reduction in two-thirds of melanoma patients, compared to 5-10 per cent reduction with chemotherapy.
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It has also shown promise in treating lung and gastric cancers. It's publicly funded in Britain, the United States, Canada, Australia and several European countries but Pharmac turned it down in November, citing a hefty $200,000-per-patient price tag and a lack of long-term data as reasons for its "low priority" classification.
Despite pressure to publicly fund the drug, Minister of Health Jonathan Coleman has said he won't override Pharmac's decision-making process.
New Zealand director of pharmaceutical company Merck Paul Smith said this week a second price offer was made to Pharmac in the week leading up to Christmas.
"They haven't bitten our hand off on the first deal, so we have created another deal which we hope gets over the line. It's consistent with other countries like Australia [that have purchased the drug]."
If a deal is struck, enough Keytruda for 340 patients could reach New Zealand by March, he said.
Spokespeople for Pharmac wouldn't comment on whether a deal is likely but said it had a good relationship with Merck and that the drug's low priority status "doesn't necessarily stop us continuing those discussions".
"We're aware that there are some other PD-1 prohibitors on the horizon," spokesman Simon England said on the decision not to fund Keytruda. "There's Ipilimumab and there's another [Nivolumab] that's just been approved in Australia. It's about seeing long-term outcome data."
But the Cancer Society of New Zealand's medical director Dr Chris Jackson said the little information Pharmac chooses to share about Keytruda is "deliberately misleading".
"Other jurisdictions that have funded the drug have all said the follow-up [data] is relatively short, but then the lives of people with melanoma are relatively short. The drug is basically good enough to fund, it's about what our priorities are.
"Pharmac actually returns unspent cash to the government every year. I think when Pharmac say they can't afford [Keytruda] that's not true."
Jackson also called the difference between Keytruda and upcoming copycat drug Nivolumab "Pepsi versus Coke".
"Why can't you fund [Keytruda] for two years, collect the data from that process and give Nivo[lumab] the ability to get registered? Then you can have a horse race for the greatest drug."
Cost-effectiveness is a giant consideration for Pharmac. Purchasing Keytruda would mean less money for other live-saving medications, a balancing act Otago University professor Tony Blakely calls "the hard, sharp end of public health care".
Blakely has developed a "rough rule of thumb" calculator to help the public better understand how much Keytruda might cost. Taking mortality curves and Pharmac's negotiation skills into account, treatment for a 65-year-old woman with advanced melanoma comes out at $54,000 per QALY (quality-adjusted life year).
It's significantly less than the initial $200,000 estimation and not far off the $45,000 per capita the World Health Organisation recommends for New Zealand's health care expenditure.
England said Pharmac had done its own QALY calculations but "that isn't something we would disclose".
Blakely said Pharmac's reluctance to share was frustrating, but that it was a very good negotiator.
"I have spoken with various medical oncologists and people who should know these numbers and they are of the opinion that that number Pharmac will pay is considerably less than that."
Brian Stephens said stories of Keytruda's success made Ged's survival seem possible during his three-month battle with the aggressive skin cancer.
"The guy in The Listener and the Sunday programme, he seemed to have as many tumours as Dad did and they seemed to have reversed," Stephens said.
"We were pinning a lot of hope on trying it. We were hoping that 50 grand would get us started and hopefully by then Pharmac would be on board."
Stephens said his family were lucky to have some time with Ged, but had expected more than the three months after his September 11 diagnosis.
"People think it's just a skin cancer but once it gets inside it's bone cancer, it's nerve, it's lung, it's everything cancer.
"It's our belief that if Keytruda was funded on September 11, he should have been on it. We were trying to fight a pretty difficult disease and it would have been very nice to see if Dad was one of the lucky ones."
Stephens would like to see the government step up to fund further clinical trials for Keytruda so that cost doesn't come back on patients' families.
"They say the $9000 [per infusion] is to cover the cost of the research. I think government could put some money towards the research.
"It's accessible for some people and if some more people try it we will have a better understanding of how successful it could be."